• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter. Product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient with an implantable pump for non-malignant pain. Per the session report from 2020-feb-06, the pump administered the following medications as of (b)(6) 2019: fentanyl (concentration: 2000 mcg, dose rate: 900. 09156 mcg/day), bupivacaine (concentration: 20 mg, dose rate: 9. 00092 mg/day), and morphine (concentration: 5. 8 mg, dose rate: 2. 61027 mg/day). It was reported that the patient indicated that over the past 6 weeks, a gradual increase in pain had occurred. The date (b)(6) 2020 is considered an approximate date of event (specific month and year known only). It was further noted that the patient had been in and out of the hospital due to diarrhea, hypotension and abdominal pain. The patient didn¿t feel boluses and possible withdrawals was further noted. The programming date from the most recent refill prior to event occurred on (b)(6) 2020. The clinical diagnosis was increase in pain. The date of test was (b)(6) 2020. A catheter access port (cap) contrast study on (b)(6) 2020 revealed normal catheter function. Actions taken to resolve the issue included reprogramming and an increase in fentanyl occurred on (b)(6) 2020. The event resulted in-patient hospitalization. Regarding etiology, it was indicated that the relationship of the event to the device or therapy was possibly related and it was indicated that there was no change in drug. The event was noted as not having been related to the implant procedure. The event was ongoing. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10026715
MDR Text Key190337419
Report Number3004209178-2020-08126
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2020 Patient Sequence Number: 1
-
-